DxH 520

GUDID 15099590679781

DxH 520 Hematology Instrument

BECKMAN COULTER IRELAND INC.

Haematological cell analyser IVD, automated

• Primary Device ID: 15099590679781
• NIH Device Record Key: 3fb83016-d346-41af-bcaa-17162799529e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxH 520
• Version Model Number: B40602
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590679781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181475

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-03-22

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